GOP report blasts FDA for ignoring warnings about drug compounders

WASHINGTON -- Sharp partisan disagreement over the cause of last fall's meningitis outbreak became apparent Tuesday as House Republicans accused the Food and Drug Administration of ignoring numerous warning signs about compounding pharmacies.

The Republican majority on House Energy and Commerce Committee issued a staff report saying the 2012 outbreak might have been prevented if the FDA had been more aggressive about acting on complaints it had received about the New England Compounding Center and its sister firm, Ameridose, both located in Massachusetts.

Tennessee has had 152 cases, including 14 deaths, second only to Michigan's 259 cases, including 15 deaths.

"But what makes this tragedy even more heartbreaking for these families is that this could have been prevented," Rep. Fred Upton, R-Michigan, Energy and Commerce chairman, said in a joint statement with Rep. Tim Murphy, R-Pa., chair of the panel's subcommittee on Oversight and Investigations.

The Republican staff report followed one strikingly different in tone released Monday by the panel's Democratic staff. The latter argued there was a regulatory gap caused by the FDA lacking adequate statutory authority over drug compounders and state pharmacy boards lacking the information and expertise to oversee them.

Compounding pharmacies make highly customized medicines called for by doctors to meet special needs.

On the other side of the Capitol, Republican Sen. Lamar Alexander of Tennessee has said he hopes to have legislation ready by late May or June that will address the FDA's regulatory authority.

But House members Tuesday repeatedly painted the FDA as not making good use of authority it already has.

A review of more than 27,000 documents, Upton and Murphy said, found a "dramatically different picture" about the outbreak than the one FDA officials painted during the committee's first hearing on it in November.

"We now know that doctors, patients, providers, and whistleblowers tried to warn FDA for years that NECC and Ameridose were operating as manufacturers and marketing their products nationwide without patient prescriptions," they said.

"The FDA was also warned about sterility and safety issues with the companies' products. Rather than do its job and protect the patients who were taking NECC and Ameridose drugs, FDA chose not to act."

They added: "We found that FDA focused on perfecting their legal reasons for inaction instead of protecting families. Even the FDA staff wanted to go back and inspect these unsanitary manufacturers. And the FDA hierarchy said 'no.'"

But Margaret A. Hamburg, FDA commissioner, vehemently disagreed with that assessment during a nearly three-hour-long appearance Tuesday before Murphy's subcommittee.

She described the evolution of large-scale compounders like NECC, with production far exceeding that of neighborhood pharmacists who compound, or mix drugs, in response to prescriptions that apply to just one patient.

"It is clear that the industry and the health care system have evolved and have outgrown the law, and FDA's ability to take action against (large-scale compounding) has been hampered by gaps and ambiguities in the law, which have led to legal challenges to FDA's authority to inspect pharmacies and take appropriate enforcement actions," Hamburg testified.

Although 1938 food and drug laws give the FDA authority over anything considered prescription medicine, the agency has traditionally left it to state agencies to oversee small-scale compounders such as neighborhood druggists.

In 1997, Congress passed the Food and Drug Administration Modernization Act, which attempted to draw a bright line between traditional compounders and those that mass-produced. It also attempted to restrict large-scale compounders from advertising their drugs for interstate sales.

In reaction, compounders successfully challenged the 1997 law in the federal courts, arguing its advertising restrictions interfered with free speech. Some rulings struck down the whole the law. Others revoked just the advertising provisions, leaving what some interpret as a legal gray area concerning the FDA's authority over large-scale compounders.

Better define all types of compounding so there is no ambiguity about the FDA's authority.

Require compounders to register with the government "so we know who's out there."

Require compounders to turn over information about adverse reactions to their products.

"I am deeply concerned we could have another tragedy," Hamburg added.
But Republicans on the panel painted the FDA as ignoring years of warnings about firms such as NECC.

Rep. Steve Scalise, R-La., repeatedly asked Hamburg to answer "yes or no" about whether anyone at FDA has been held accountable for ignoring warnings about compounders.
At one point Hamburg responded, "We could have been more rigorous."